MP54-12 PROSPECTIVE RANDOMIZED TRIAL OF GENE EXRESSION CLASSIFIER UTILTY IN MEN AT HIGH RISK OF RECURRENCE FOLLOWING RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy III (MP54)1 Apr 2019MP54-12 PROSPECTIVE RANDOMIZED TRIAL OF GENE EXRESSION CLASSIFIER UTILTY IN MEN AT HIGH RISK OF RECURRENCE FOLLOWING RADICAL PROSTATECTOMY Todd Morgan*, Linda Okoth, Felix Feng, Anna Johnson, Brian Lane, Susan Linsell, Khurdish Ghani, James Montie, Nick Fishbane, Tara Marti, Marguerite du Plessis, Rohit Mehra, Elai Davicioni, Thomas Maatman, Kirk Wojno, Frank Burks, Paul Rodriguez, Nick Liu, Richard Sarle, David Miller, Michael Cher, and Michigan Urological Surgery Improvement Collaborative Todd Morgan*Todd Morgan* More articles by this author , Linda OkothLinda Okoth More articles by this author , Felix FengFelix Feng More articles by this author , Anna JohnsonAnna Johnson More articles by this author , Brian LaneBrian Lane More articles by this author , Susan LinsellSusan Linsell More articles by this author , Khurdish GhaniKhurdish Ghani More articles by this author , James MontieJames Montie More articles by this author , Nick FishbaneNick Fishbane More articles by this author , Tara MartiTara Marti More articles by this author , Marguerite du PlessisMarguerite du Plessis More articles by this author , Rohit MehraRohit Mehra More articles by this author , Elai DavicioniElai Davicioni More articles by this author , Thomas MaatmanThomas Maatman More articles by this author , Kirk WojnoKirk Wojno More articles by this author , Frank BurksFrank Burks More articles by this author , Paul RodriguezPaul Rodriguez More articles by this author , Nick LiuNick Liu More articles by this author , Richard SarleRichard Sarle More articles by this author , David MillerDavid Miller More articles by this author , Michael CherMichael Cher More articles by this author , and Michigan Urological Surgery Improvement Collaborative More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000556683.01213.eaAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: The Decipher assay is a tissue-based genomic classifier (GC) developed and validated in the post-radical prostatectomy (RP) setting as a predictor of metastasis. Retrospective evidence suggests that patients with a high GC score may benefit from adjuvant radiotherapy, while observation may be safe for those with a lower GC score. We sought to conduct the first prospective randomized trial assessing the impact of GC testing on adjuvant therapy use in this setting and report here patient characteristics and risk distribution of the cohort. METHODS: The Genomics in Michigan ImpactiNg Observation or Radiation (G-MINOR) study enrolled 356 participants across 13 sites between January 2017-August 2018. Eligible patients had undergone RP within 9 months of enrollment, had pT3-4 and/or positive surgical margins, and a post-RP PSA <0.1ng/mL. Patients were assigned to either the GC or Usual-Care-Based (UC) group using cluster-crossover block randomization assignments. Patients in both arms received a CAPRA-S derived predicted risk of recurrence. If enrolled during the GC period, the subject and physician were also provided with the Decipher score. Decipher results were assessed centrally in UC patients but were not available to clinicians or patients. Clinical data, including CAPRA-S and Decipher scores, were compared between arms. RESULTS: We report on 356 patients that met the inclusion criteria and whose RP tissue passed the required QC thresholds. Of these patients, 182 (51.1%) and 174 (48.9%) were randomized to the GC and UC groups, respectively. Between study arms, we found no statistically significant difference in the frequency of extraprostatic extensions, seminal vesicle invasion, or surgical margins; nor did we find a difference in distribution of Gleason grade, pre-operative PSA, or CAPRA-S score. Based on the Decipher scores, the risk of metastasis within 5-years of RP had a median (IQR) of 6.0% (2.4%-16.8%) in the GC group and 6.9% (2.6%-19.5%) in the UC group (Wilcoxon p=0.45). CONCLUSIONS: In this biomarker-driven clinical trial of men following RP, baseline clinical variables, CAPRA-S risk, and Decipher scores were similar in the two study arms. With completion of enrollment, these data indicate the study will be appropriately powered to measure rates of post-operative radiation within 18 months from surgery and rates of metastasis within 5 years from surgery. Source of Funding: GenomeDx Biosciences Blue Cross Blue Shield of Michigan Ann Arbor, MI; San Francisco, CA; Ann Arbor, MI; Grand Rapids, MI; Ann Arbor, MI; Vancouver, Canada; Ann Arbor, MI; Vancouver, Canada; Grand Rapids, MI; Royal Oak, MI; Grand Rapids, MI; Ypsilanti, MI; Troy, United Kingdom; Ann Arbor, MI; Detroit, MI; Ann Arbor, MI© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e789-e789 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Todd Morgan* More articles by this author Linda Okoth More articles by this author Felix Feng More articles by this author Anna Johnson More articles by this author Brian Lane More articles by this author Susan Linsell More articles by this author Khurdish Ghani More articles by this author James Montie More articles by this author Nick Fishbane More articles by this author Tara Marti More articles by this author Marguerite du Plessis More articles by this author Rohit Mehra More articles by this author Elai Davicioni More articles by this author Thomas Maatman More articles by this author Kirk Wojno More articles by this author Frank Burks More articles by this author Paul Rodriguez More articles by this author Nick Liu More articles by this author Richard Sarle More articles by this author David Miller More articles by this author Michael Cher More articles by this author Michigan Urological Surgery Improvement Collaborative More articles by this author Expand All Advertisement PDF downloadLoading ...

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